HOUSTON, June 04, 2007 /PRNewswire/ -- A nationally renowned
cancer researcher affiliated with the US Oncology Research Network
presented a novel study design concept called a Complete Phase Ib
clinical trial as a method to accelerate new agent development.
Studies utilizing this design are currently being conducted through
the network's innovative Translational Oncology Program (TOP). TOP
is unique because it conducts early phase trials in a community
setting. These types of trials are usually carried out in academic
medical centers.

The study results were presented in a poster session by Daniel
Von Hoff, M.D., Chief Scientific Officer for the US Oncology
Research Network, at the 43rd Annual Meeting of the American
Society of Clinical Oncology (ASCO) held June 2-5, 2007 in Chicago.
In addition, 22 physicians and researchers affiliated with US
Oncology participated in oral and poster presentations, moderated
panels and published studies at this year's ASCO conference in
Chicago. The researchers presented findings on a variety of disease
states including lung, gastrointestinal, genitourinary,
gynecologic, breast and melanoma.

The study, titled "The Complete Phase Ib Clinical Trial: A
Method to Accelerate New Agent Development" tested the hypothesis
that within a single protocol, several combination phase I trials
could be conducted simultaneously

Background for this study indicates that the usual clinical
development plan for a new agent (NA) includes a phase I
monotherapy trial. However, because many new agents are eventually
developed as part of a combination of agents, additional phase I
trials assessing the new agent in combination with a standard agent
are usually performed (usually as individual phase Ib studies).

Agents vary from study to study, based on preclinical modeling,
which is the basis for which drugs are utilized in studies.

The design of the protocol is (assum
ing the new agent is
synergistic with an anthracycline, a tubulin interactive agent, an
antimetabolite, or an angiogenesis inhibitor of an antibody to
epidermal growth factor receptor, EGFR) patients with advanced
cancer are treated with the combination deemed most likely to be of
help, with a choice of anthracycline + new agent (NA); tubulin
interactive + NA; antimetabolite + NA; angiogenesis inhibitor + NA;
and an antibody to EGFR + NA.

The standard agent is started at full dose with three patients
placed at 1/3 full dose of NA, three patients at 2/3 dose of NA,
and three-six patients at full dose of the NA in the combination.
The trial looks at combinations of drugs with different agents
utilized in the study. Additive properties of combination drugs,
rather than minimal threshold, were studied, indicating the use of
two drugs given together with no detrimental effects.

The research found that the Complete Phase Ib trial has several
advantages over conducting separate phase I trials. The advantages
include: a very rapid follow-up on preclinical data in one study; a
saving of time and expense in the start up; rapid accrual because
many patients in a practice are likely to be eligible (e.g. the
standard agent is the standard of care); patients are often less
pretreated; and the trial generates information for more informed
selection of follow-up randomized phase II or III trials.

The research concluded that using a Complete Phase Ib trial
design is feasible. The initial experience has suggested that this
approach is safe and highly efficient with several potential
advantages over multiple sequential combination phase Ib
studies.

"Our US Oncology research team is confident that the methodology
described in our poster will significantly shorten the time it
takes to bring new therapies into the daily care for patients with
cancer," said Dr. Von Hoff.

Phase I trials are the initial step in testing new treatments in
humans. Their main
focus is to evaluate a drug's safety, including
safe dosage range. Phase Ib studies are typically combinations of
the new agent plus a standard agent.

The Translational Oncology Program (TOP) was founded in 2004
following a request from physicians affiliated with US Oncology to
establish an early phase study program. TOP is comprised of a
select group of US Oncology physicians who address standard Phase I
study design and select Phase II studies. Members of the US
Oncology Research Network met with investigators in January 2005
and TOP began its first study two months later. The program's goals
include establishing a Phase I research infrastructure, eventually
incorporating targeted therapy into its research efforts.

"What's exciting is that as TOP has evolved, the US Oncology
Research Network has taken on more Phase I and II trials that are
typically the newest, and often, the most novel approaches to
cancer treatment that will ultimately benefit our patients," said
Jeffery Nieves, Pharm D., Director or the Translational Oncology
Program for the US Oncology Research Network.

"Early-stage trials conducted in a smaller, community setting
can result in a speedier determination of a new agent's viability,
eventually bringing new therapies to patients quicker."

Each TOP site is required to have a dedicated physician,
research nurse and investigational/research pharmacist who have the
experience and credentials to conduct phase I trials. In addition,
each site must meet facility and equipment requirements to
participate in early-stage trials.

TOP rounds are conducted weekly at each site and include an
assessment of patient status and safety for all participants, a
review of pending and priority protocol status, and discussion of
new scientific concepts. In 2007, the 200th patient was accrued to
a TOP trial.

About US Oncology Research

The US Oncology Research Network is an established
community-based research operation spec
ializing in all phases of
cancer clinical trials. The research network currently has 528
physicians actively enrolling patients, 82 research sites, and is
currently involved in 65 open research trials. The network has
contributed to the development of 24 of 30 of the latest cancer-
fighting drugs approved by the Food and Drug Administration for
use. Since 1993, more than 32,000 patients have participated in
clinical trials managed by US Oncology network practices. For more
information, visit the "Research" section under "Our Services" on
the company's Web site, www.usoncology.com.

About US Oncology, Inc.

US Oncology, headquartered in Houston, is one of the nation's
largest cancer treatment and research networks. US Oncology
provides extensive services and support to its affiliated cancer
care sites nationwide to help them expand their offering of the
most advanced treatments and technologies, build integrated
community-based cancer care centers, improve their therapeutic drug
management programs, and participate in many of the new
cancer-related clinical research studies. US Oncology also provides
a broad range of services to pharmaceutical manufacturers,
including product distribution and informational services such as
data reporting and analysis.

According to the company's last quarterly earnings report, US
Oncology is affiliated with 1077 physicians operating in 433
locations, including 90 radiation oncology facilities in 38
states.

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